NCT02285647View on ClinicalTrials.gov

An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant

PHASE1CompletedINTERVENTIONAL

Enrollment

138

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

May 31, 2015

Conditions

Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

Rolapitant - Oral

Oral Treatment A Investigational Product: Rolapitant Dose: 200 mg (4 x 50 mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight)

DRUG

Rolapitant - IV

IV Treatment B Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight)

Trial Locations (1)

21225

Parexel, Baltimore

All Listed Sponsors

lead

Tesaro, Inc.

INDUSTRY

NCT02285647 - An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant | Biotech Hunter | Biotech Hunter